Influence of Spinal Stimulation Frequency on Spasticity, Motor Control, and Pain After Spinal Cord Injury

Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation (Phase II)

The goal of this study is to identify the effect of different types of noninvasive spinal stimulation on spasticity (involuntary muscle activity), muscle strength, and pain in people with spinal cord injury. The spinal stimulation consists of electrical stimulation applied through one electrode over the skin of the lower back and two electrodes over the stomach. Testing will include participating in measurements before the intervention, during intervention, and immediately after the intervention. This study requires participants to come into Shepherd Center 4 consecutive days a week for 2-3 hours per day across 2-3 weeks.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Transcutaneous Spinal Stimulation

Detailed Description

Transcutaneous spinal stimulation (TSS) is a noninvasive electrical stimulation that is applied over the skin of the low back and stomach. In prior research studies, TSS has reduced spasticity without the negative side effects of drug therapies. Although research in TSS is growing, the best dosage of TSS remains unknown. The investigators want to further advance the effects of TSS by comparing three different frequencies. Frequency is the number of electrical pulses that are delivered over a period of time. Frequency can affect the activation of nerves and therefore affect the outcome of TSS. Participation in this study includes testing of the participants' spasticity, strength, and pain before and after 30 minutes of TSS.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly Thatcher, PT, DPT; Phone Number: 404-350-7681; Email: kelly.thatcher@shepherd.org
• Study Contact Backup: Name: Evan Sandler, PT, DPT; Phone Number: 404-603-4175; Email: evan.sandler@shepherd.org

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Shepherd Center, Inc.
      • Contact: Evan Sandler, PT, DPT; Phone Number: (404) 603-4175; Email: evan.sandler@Shepherd.org
      • Contact: Kelly Thatcher, PT,DPT; Phone Number: 404-350-7681; Email: kelly.thatcher@shepherd.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must agree to allow use of health information.
• Participants should be 16 years old or older.
• Participants must have had a spinal cord injury (SCI) of any severity (AIS A, B, C, or D) that happened at least 3 months ago.
• Participants should have at least a small amount of spasticity in the legs.
• Participants must inform the investigators if there is a change in medications during the study.
• Participants must be able to follow instructions.
• Participants must be able to communicate if pain or discomfort is experienced.

Exclusion Criteria:

• People with spinal issues that are getting worse, such as degenerative or progressive vascular disorders.
• People neurological problems other than SCI.
• People with an injury level is below T12.
• People with heart issues, such as atrial fibrillation.
• People with bone or joint problems that would make it hard to follow the study plan.
• Women who are pregnant.
• People with implanted stimulators (like a baclofen pump, spinal stimulator, heart defibrillator, or diaphragmatic pacemaker)
• People with infection.
• People with skin that is broken.
• People who have or had certain types of cancer.
• People who have had long-lasting spasticity treatment (like botox or selective dorsal rhizotomy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30 Hz Frequency; Intervention will be applied with a 30 Hz frequency.	Other: Transcutaneous Spinal Stimulation; Transcutaneous spinal stimulation will be delivered for 30 minutes using biphasic pulses. A single cathode electrode will be placed over the skin of the back spine at the T11/T12 spinous interspace. Two reference electrodes will be placed over the stomach. Stimulation intensity will be set to 0.8x reflex threshold, as determined by posterior root muscle reflex testing before the intervention. Treatments will be a minimum of 72 hours apart.
Experimental: 50 Hz Frequency; Intervention will be applied with a 50 Hz frequency.	Other: Transcutaneous Spinal Stimulation; Transcutaneous spinal stimulation will be delivered for 30 minutes using biphasic pulses. A single cathode electrode will be placed over the skin of the back spine at the T11/T12 spinous interspace. Two reference electrodes will be placed over the stomach. Stimulation intensity will be set to 0.8x reflex threshold, as determined by posterior root muscle reflex testing before the intervention. Treatments will be a minimum of 72 hours apart.
Experimental: 80 Hz Frequency; Intervention will be applied with an 80 Hz frequency.	Other: Transcutaneous Spinal Stimulation; Transcutaneous spinal stimulation will be delivered for 30 minutes using biphasic pulses. A single cathode electrode will be placed over the skin of the back spine at the T11/T12 spinous interspace. Two reference electrodes will be placed over the stomach. Stimulation intensity will be set to 0.8x reflex threshold, as determined by posterior root muscle reflex testing before the intervention. Treatments will be a minimum of 72 hours apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pendulum Test	During the pendulum test, the participant will be lying on a therapy mat with the lower leg hanging off the edge of the mat. A member of the study staff will support the participant's extended lower leg and then release the leg allowing it to swing freely. This test will be video recorded and the movement of the knee joint will be measured using software on the computer.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle Clonus Test	During the ankle clonus test, the participant will be seated at the edge of a mat with the lower leg hanging over the mat. A member of the study staff will support the participant's leg above a box and then release the leg allowing the front of the foot to land on the edge of the box. This test will be video recorded and the movement of the ankle joint will be measured using software on the computer.	15 minutes
Stimulation Tolerability Questionnaire	Participants will be asked to rate how tolerable the spinal stimulation was during the session and to describe specific sensations that contributed to this rating.	2 minutes
Muscle activation	Participants will be asked to activate different leg muscles and produce the maximum amount of force possible. Muscle activation will be measured through sensors placed on the muscles and force production will be measured using a dynamometer.	20 minutes
Posterior root muscle reflexes	Posterior root muscle reflexes will be used to measure spinal reflex excitability. These reflexes will also be used to determine the intensity of stimulation that is applied during the intervention (0.8x soleus reflex threshold). During this test, participants have a single electrode over the skin of the back (T11/12) and two electrodes over the stomach (umbilicus). Brief pulses of stimulation will be applied at gradually increasing intensities while measuring muscle responses in different leg muscles.	25 minutes
Nociception/Pain	The investigators will measure nociception using the flexor reflex. The flexor reflex measures muscle responses to an unpleasant stimulus. Electrodes will be placed at the bottom of the foot. First, the investigators will measure muscle responses to a single stimulus (25 mA). Next, the investigators will measure muscle responses to 5 consecutive stimuli (25 mA). The investigators will then ask participants to rate the unpleasant stimulus on a scale of 0-10.	15 minutes
Quality of Spasticity Questionnaire	The Qualities of Spasticity Survey is a self-report questionnaire that asks participants about the physical qualities of their spasticity and how it impacts daily life. Participants will be asked to report experience with spasticity over the past 48 hours.	5 minutes
Modified Penn Spasm Frequency Scale	The Modified Penn Spasm Frequency Scale is a self-report questionnaire that asks participants to rate the frequency and severity of spasms during the last hour.	2 minutes
Global Rating of Change Scale	Participants will be asked to rate how much their change in spasticity affects their daily life.	1 minute

Collaborators and Investigators

• Sponsor: Shepherd Center, Atlanta GA
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Edelle C Field-Fote, PT, PhD, Shepherd Center, Atlanta GA

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 2111327; 1R01HD101812-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No